Academic Journal
MONARCH plus: abemaciclib plus endocrine therapy in women with HR+/HER2– advanced breast cancer: the multinational randomized phase III study
| العنوان: | MONARCH plus: abemaciclib plus endocrine therapy in women with HR+/HER2– advanced breast cancer: the multinational randomized phase III study |
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| المؤلفون: | Qing Yuan Zhang, Tao Sun, Yong Mei Yin, Hui Ping Li, Min Yan, Zhong Sheng Tong, Christina P. Oppermann, Yun Peng Liu, Romulo Costa, Man Li, Ying Cheng, Qu Chang Ouyang, Xi Chen, Ning Liao, Xin Hong Wu, Xiao Jia Wang, Ji Feng Feng, Roberto Hegg, G.B. Kanakasetty, Maria A. Coccia-Portugal, Ru Bing Han, Yi Lu, Hai Dong Chi, Ze Fei Jiang, Xi Chun Hu |
| المصدر: | Therapeutic Advances in Medical Oncology, Vol 12 (2020) |
| بيانات النشر: | SAGE Publishing, 2020. |
| سنة النشر: | 2020 |
| المجموعة: | LCC:Neoplasms. Tumors. Oncology. Including cancer and carcinogens |
| مصطلحات موضوعية: | Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282 |
| الوصف: | Aim: To compare the efficacy, safety, and tolerability of abemaciclib plus endocrine therapy (ET) versus ET alone in postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer (ABC) from China, Brazil, India, and South Africa. Methods: This randomized, double-blind, phase III study was conducted between 9 December 2016 and 29 March 2019. Postmenopausal women with HR-positive, HER2-negative ABC with no prior systemic therapy in an advanced setting (cohort A) or progression on prior ET (cohort B) received abemaciclib (150 mg twice daily) or placebo plus: anastrozole (1 mg/day) or letrozole (2.5 mg/day) (cohort A) or fulvestrant (500 mg per label) (cohort B). The primary endpoint was progression-free survival (PFS) in cohort A, analyzed using the stratified log-rank test. Secondary endpoints were PFS in cohort B (key secondary endpoint), objective response rate (ORR), and safety. This interim analysis was planned after 119 PFS events in cohort A. Results: In cohort A, 207 patients were randomly assigned to the abemaciclib arm and 99 to the placebo arm. Abemaciclib significantly improved PFS versus placebo (median: not reached versus 14.7 months; hazard ratio 0.499; 95% confidence intervals (CI) 0.346–0.719; p = 0.0001). ORR was 65.9% in the abemaciclib arm and 36.1% in the placebo arm ( p |
| نوع الوثيقة: | article |
| وصف الملف: | electronic resource |
| اللغة: | English |
| تدمد: | 1758-8359 17588359 |
| Relation: | https://doaj.org/toc/1758-8359 |
| DOI: | 10.1177/1758835920963925 |
| URL الوصول: | https://doaj.org/article/97a1aeef27ca442790bae5374547f9e7 |
| رقم الانضمام: | edsdoj.97a1aeef27ca442790bae5374547f9e7 |
| قاعدة البيانات: | Directory of Open Access Journals |
Full Text Finder | تدمد: | 17588359 |
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| DOI: | 10.1177/1758835920963925 |